The U.S. Food and Drug Administration (FDA) announced on Wednesday (October 29) a plan to streamline the approval process for biosimilars , which are generic versions of complex biological drugs. These changes aim to reduce drug costs and increase market competition by making it easier and less costly to develop these alternatives. Biologic drugs, made from living organisms, are more complex than chemically derived drugs, requiring a unique FDA approval process. Biosimilars, although not exact copies, serve as alternatives to brand-name biologics.

The FDA's new draft guidance proposes reducing the need for expensive and lengthy comparative human clinical studies , allowing developers to rely more on analytical testing. This move is expected to facilitate the development of interchange

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